NPseal Large

GUDID 00860004811336

NPseal Large Advanced Negative Pressure Dressing (box of 10, Large)

Guard Medical Inc.

Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial

• Primary Device ID: 00860004811336
• NIH Device Record Key: f739a36b-4582-491d-ae66-ef4a311fd685
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NPseal Large
• Version Model Number: GM01-003
• Company DUNS: 118095992
• Company Name: Guard Medical Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com
• Phone: 8884173644
• Email: info@guard-medical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage
• Handling Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture during storage

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004811336 [Unit of Use]
GS1	10860004811333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212971

FDA Product Code

• OKO: Negative Pressure Wound Therapy Non-Powered Suction Apparatus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-08
• Device Publish Date: 2022-08-31

Devices Manufactured by Guard Medical Inc.

• 00860004811329 - NPseal Medium: 2022-09-08 NPseal Medium, Advanced Negative Pressure Dressing (box of 10, Medium)
• 00860004811336 - NPseal Large: 2022-09-08NPseal Large Advanced Negative Pressure Dressing (box of 10, Large)
• 00860004811336 - NPseal Large: 2022-09-08 NPseal Large Advanced Negative Pressure Dressing (box of 10, Large)
• 00860004811305 - NPseal (5): 2021-06-15 NPseal Advanced Negative Pressure Dressing (box of 10, small)